Premier Toxins a&B, Model 616096

• • Terminated Z-0062-04 FDA Unclassified (pre-2012) ·initiated 23 Sep 2003

  The kits were packaged with incorrect dispensing pipettes.

• • Terminated Z-0464-03 FDA Unclassified (pre-2012) ·initiated 26 Dec 2002 ·on shared 510(k) K993914

  Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K993914 ↗

FDA Product Code

LLH

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Blastomyces Dermatitidis Antigen (JWW)

  Class II

  FDA 510(k) K792680 Active Cleared 17 Jan 1980

• Candida Albicans, Antiserum

  Class II

  FDA 510(k) K792713 Active Cleared 23 Jan 1980

• Lacto-Phenol Analine Blue Fluid

  Class I

  FDA 510(k) K792703 Active Cleared 24 Jan 1980

• Immunocard Mycoplasma

  Class I

  FDA 510(k) K934550 Active Cleared 20 Sep 1994

• Histoplasma Capsulatum, Antiserum

  Class II

  FDA 510(k) K792718 Active Cleared 17 Jan 1980

• Blastomyces Dermatitidis, Antiserum

  Class II

  FDA 510(k) K792685 Active Cleared 17 Jan 1980

See all devices from Meridian Diagnostics, Inc. →